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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K901236
Device Name RUBBER, DENTAL DAM (NON-STERILE)
Applicant
Naturub Sdn. Bhd.
Lot 67/8 Lrg. Senawang 4/1
70450 Seremban
Malaysia,  MY
Applicant Contact MISS M AZIZAH
Correspondent
Naturub Sdn. Bhd.
Lot 67/8 Lrg. Senawang 4/1
70450 Seremban
Malaysia,  MY
Correspondent Contact MISS M AZIZAH
Regulation Number872.6300
Classification Product Code
EIE  
Date Received03/15/1990
Decision Date 06/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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